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Clobazam

Generic Name
Clobazam
Brand Names
Onfi, Sympazan
Drug Type
Small Molecule
Chemical Formula
C16H13ClN2O2
CAS Number
22316-47-8
Unique Ingredient Identifier
2MRO291B4U

Overview

Clobazam belongs to the 1,5-benzodiazepine class of drugs and is marketed under different names, Onfi, Frisium, Urbanyl, and others.. Clobazam was first synthesized in 1966 and first published in 1969, following the incidental synthesis and discovery of the first benzodiazepine chlordiazepoxide in the 1950s. Unlike older 1,4-benzodiazepines, clobazam has a better side-effects profile, particularly less sedative and amnesic effects. This is likely because of clobazam's higher affinity to the α subunit of the GABA receptor, which mediates anxiolytic effects, than the α subunit, which mediates sedative effect. Additionally, clobazam is believed to be a partial agonist to the GABA receptor rather than non-selective full receptor agonists like 1,4-benzodiazepines, thus potentially explaining the decreased incidence of sedative effects. Clobazam has been marketed as an anxiolytic since 1975 and an anticonvulsant since 1984. In October 21, 2011, the FDA approved clobazam as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children aged two years and older. In 2005, clobazam also received approval from Health Canada as an add-on therapy for generalized tonic-clonic, myoclonic, and focal impaired awareness seizures.

Background

Clobazam belongs to the 1,5-benzodiazepine class of drugs and is marketed under different names, Onfi, Frisium, Urbanyl, and others.. Clobazam was first synthesized in 1966 and first published in 1969, following the incidental synthesis and discovery of the first benzodiazepine chlordiazepoxide in the 1950s. Unlike older 1,4-benzodiazepines, clobazam has a better side-effects profile, particularly less sedative and amnesic effects. This is likely because of clobazam's higher affinity to the α subunit of the GABA receptor, which mediates anxiolytic effects, than the α subunit, which mediates sedative effect. Additionally, clobazam is believed to be a partial agonist to the GABA receptor rather than non-selective full receptor agonists like 1,4-benzodiazepines, thus potentially explaining the decreased incidence of sedative effects. Clobazam has been marketed as an anxiolytic since 1975 and an anticonvulsant since 1984. In October 21, 2011, the FDA approved clobazam as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children aged two years and older. In 2005, clobazam also received approval from Health Canada as an add-on therapy for generalized tonic-clonic, myoclonic, and focal impaired awareness seizures.

Indication

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Associated Conditions

  • Anxiety
  • Catamenial Epilepsy
  • Refractory Status Epilepticus
  • Seizures
  • Status Epilepticus

FDA Approved Products

Clobazam
Manufacturer:Micro Labs Limited
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/03/20
NDC:42571-315
clobazam
Manufacturer:Breckenridge Pharmaceutical, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/01/01
NDC:51991-900
clobazam
Manufacturer:Breckenridge Pharmaceutical, Inc.
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/01/01
NDC:51991-958
Clobazam
Manufacturer:Taro Pharmaceuticals U.S.A., Inc.
Route:ORAL
Strength:2.5 mg in 1 mL
Approved: 2023/04/17
NDC:51672-4227
Clobazam
Manufacturer:Upsher-Smith Laboratories, LLC
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/05/31
NDC:0832-0581

Singapore Approved Products

FRISIUM 10 TABLET 10 mg
Manufacturer:Opella Healthcare International SAS
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1988/06/01
Approval:SIN01591P

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